Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00049842

Purpose

The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).

Condition	Intervention	Phase
Chronic Hepatitis C Liver Fibrosis	Biological: peginterferon alfa-2b (SCH 54031)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370)

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon alfa-2b Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3). [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
Definitions:

Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).

Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.

No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.

Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.

Secondary Outcome Measures:

Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).

Changes in liver inflammation defined as follows:

Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.

No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.

Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.

Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis).
The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
Definitions:

Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).

Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.

No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.

Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Mean Change in the METAVIR Activity Score (Using a Continuous Scale) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.

Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis).
Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment. [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
Definitions:

Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).

Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.

No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.

Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.

Enrollment:	540
Study Start Date:	October 2002
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW) PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up	Biological: peginterferon alfa-2b (SCH 54031) 0.5 µg/kg Weekly QW SC for 36 months
No Intervention: Untreated Control

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age at entry in study P02370 (NCT00039871) 18-65 years;
Nonresponder to PEG-Intron plus Rebetol in study P02370

Exclusion Criteria:

Participants who did not participate in the P02370 study.
Any medical condition, including but not limited to decompensated liver disease, malignancy or substance abuse, that developed during the P02370 study which could interfere with the participant's participation in and completion of this study.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00049842 History of Changes
Other Study ID Numbers:	P02570
Study First Received:	November 14, 2002
Results First Received:	October 7, 2010
Last Updated:	March 25, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Fibrosis
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Cirrhosis
Hepatitis C, Chronic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases

Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012